Collagen Markers in Heart Failure and Preserved Ejection Fraction

Terminated

• Conditions: Left-sided Congestive Heart Failure

• Registration Number: NCT01677494
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics

Detailed Description

Heart failure (HF) is a growing public health problem. While HF with deteriorated ejection fraction has faced numbers of (non) pharmacological advances, HF with preserved ejection fraction, which represents half of admission has today no efficient treatment.

Fibrosis is found in heart of patients with HF and preserved ejection fraction, is reponsible for stiff heart and has link to the transition to compensated/decompaseted HF and death.

The purpose of this work is to characterise myocardial fibrosis by any means to change the prognosis of patients with HF and preserved ejection fraction

Main purpose:

Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics

* Patients selection

1. - Inclusion Criteria: Male or female \> 18 and \< 85 years of age. Recent HF decompensation (framingham criteria, ejection fraction \> 50% with 72 hours after admission and BNP \> 100 ng/L or NT-proBNP \> 300 ng/L), signed inform consent.

2. - exclusion criteria: hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, significant respiratory disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high cardiac output HF, isolated right ventricular dysfunction, pregnancy or child-bearing, biventricular pacing, No health insurance.

* Control group

1. - inclusion criteria: Male or female \> 18 and \< 85 years of age. signed inform consent. Health insurance.

2. - exclusion criteria: significant ischemic heart disease, significant valvular heart disease, pericarditis, pulmonary hypertension, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, significant respiratory disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high cardiac output HF, isolated right ventricular dysfunction, pregnancy or child-bearing, biventricular pacing, No health insurance.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-09-03
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-01
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
death and admission for heart failure	2 years

Trial Locations

Locations (1)

Rouen university hospital; 🇫🇷 Rouen, France